Industry RegulationsHow is Feed and Pet Food Regulated in the U.S.?
Animal feed and pet food (also referred to jointly as “animal food”) are regulated by both federal and state law. Every state in the U.S., except Alaska, which has no feed industry, has a feed law. Moreover, there is a national food and feed law, the Federal Food, Drug and Cosmetic Act, administered by the U.S. Food and Drug Administration. In this national law, food is defined as “food for man or animals.” This ultimately means the regulators treat feed as food in their regulatory duties. Much of the approval process for feed ingredients is very similar if not the same as for food products. The primary difference, however, is that feed must be safe for both animals and the people consuming the animal products.
State feed laws were first adopted in 1885 with many states implementing feed laws by 1905. The first feed laws were truth-in-labeling laws to protect farmers from receiving “junk” feed. There were considerable differences among and between these laws making feed commerce between states a very difficult area of business.
The was formed in 1909. AAFCO consists of state and federal feed regulators. It develops all the legal feed definitions for use on feed labels in concert with FDA. It is illegal to use an ingredient in the U.S. that has not been defined by AAFCO (or, in rare cases, the state feed authority). These legal definitions and their changes each year are published annually by AAFCO in its “Official Publication.” The approval process for feed ingredients is a joint effort by FDA and AAFCO. FDA does the technical review and AAFCO maintains the listing of approved ingredients.
AAFCO also works to promote uniformity of feed laws by maintaining an AAFCO Model Feed Bill and Regulations, which is endorsed by AFIA. Every state feed law utilizes the general structure of the Model Feed Bill and Regulations, but some states have not adopted the most recent version.
Under federal law, any feed ingredient used in feed or pet food must be either an approved food additive by FDA or Generally Recognized as Safe for its intended use. State laws require the ingredient to either be defined and listed in a “positive” list by AAFCO in the “Official Publication” or have a recognized “common or usual name” in order to be legally used in feed.
Generally, an ingredient that provides nutrients must not have a label that claims to do other things, such as increased milk production. Ingredient labels that claim or the products are intended to cure, prevent, treat or mitigate disease conditions or change the structure or function of the body (unless the ingredient is a food that accomplishes this, such as calcium for bones) are considered drugs under the Federal Food, Drug and Cosmetic Act and require a long process for approval to make such claims.
If a firm develops a new ingredient, then it may not be used in feed unless FDA approves of that use. The AAFCO ingredient review and the Food Additive Petition (FAP) processes are now very similar. In either, FDA requires the firm to supply animal and human safety data, analytical methodology, detailed lists of the manufacturing processes, toxicology on any harmful substances in the ingredient, data to show the ingredient will be manufactured consistently and a proposed legal definition for the product.
If during the AAFCO review process, FDA finds any potential problems in the data submitted, then the agency may require a more formal FAP be submitted. A FAP typically will require more data and several more years for FDA review.
Every facility that manufacturers, processes, packs or holds food (including animal food) is required to register their facility with FDA. This initial registration took place in 2003. Amendments in the Food Safety Modernization Act now require facilities to reregister their facility every two years in the even numbered years between Oct. 1 and Dec. 31.
Current Good Manufacturing Practices
Federal and state feed laws in the U.S. rely on process controls utilizing Current Good Manufacturing Practices regulations (CGMPs). Federal CGMPs for medicated feeds have been in place in the U.S. for more than 35 years in 21 CFR 225. Non-medicated feed and pet food currently do not have federal mandated CGMPs, however FDA is in the process of promulgating such regulations.
AAFCO has recently approved Model Good Manufacturing Practices Rules for Feed and Feed Ingredients. These rules cover feed, pet food and feed ingredients. In order to be effective, each state must adopt them.
As noted above, medicated feed must comply with the medicated CGMP rules, which mandate correct labeling, correct recordkeeping, some testing of medicated feed, precise and accurate equipment, control of incoming animal drugs and outgoing product, and other issues. A federal license is required to purchase concentrated animal drug premixes requiring withdrawal times in market animals. Slightly more than 1,000 feed mills hold this type of Medicated Feed Mill License. By holding a license, FDA is required to inspect a mill every two years for compliance with these GMP regulations. FDA contracts with more than 30 state regulatory officials to conduct inspections as FDA officers. Compliance is excellent and many non-compliance issues involve policy differences or interpretations. FDA typically seeks consent decrees from licensed firms with a pattern or history of deviations from the CGMPs.
Food Safety Modernization Act
The Food Safety Modernization Act (FSMA) was signed into law on January 4, 2011, and provides FDA with sweeping new authorities and requirements. The law was a bi-partisan supported bill backed by the food and feed industries. It authorizes FDA to promulgate new rules for preventive controls, develop performance standards, create new administrative detention rules, provides authority for mandatory recall of adulterated products and provides authority for hiring more than 4,000 new field staff among other provisions. It is unclear whether Congress will provide sufficient funding authorization to fully implement the law.